KETOCONAZOLE Recall D-1065-2022
Description: Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60
KETOCONAZOLE Recall D-1065-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1065-2022 |
| Event ID | 89646 |
| Brand | KETOCONAZOLE |
| Generic Name | KETOCONAZOLE |
| Manufacturer | KETOCONAZOLE |
| Original Package? | 1 |
| Active Substance | KETOCONAZOLE |
| Drug Route | TOPICAL |
| Distribution | USA nationwide. |
| Quantity | 6 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0168-0099 |
| Product NUI | N0000175487 M0002083 N0000182141 |
| Drug UPC | 0301680099156 |
| Pharma Class (EPC) | Azole Antifungal [EPC] |
| Pharma Class (CS) | Azoles [CS] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | R9400W927I |
| Drug Application Number | ANDA076294 |
| Structured Product Labeling (SPL ID) | b4ef7400-7e35-47f2-bd1c-3c5e15cc90ee |
| Structured Product Labeling (SPL Set ID) | cad7c647-34a9-4e4e-83b3-8d78e58f588f |
| Similar To |